Efficacy and Safety of Madalena Association in the Treatment of Type II Diabetes Mellitus

• Status: Not yet recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of Madalena association in the treatment of type 2 diabetes mellitus.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMS
• Treatments: Empagliflozin; Linagliptin; Metformin

Criteria

Inclusion Criteria:

• Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;

• Participants with 18 years of age or greater;

• Participants presenting the diagnosis of type II diabetes mellitus, and who did not reach the therapeutic goals of HbA1c with previous dietary, physical exercise guidance and at least 3 months with two anti-hyperglycemic agents (dual therapy);

• HbA1c ≥ 7,5% and ≤ 10,5% and fasting blood glucose > 100 mg/dL at the screening visit;

• BMI (body mass index) > 19 Kg/m2 and ≤ 45 Kg/m2.

Exclusion Criteria:

• Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;

• History of alcohol abuse or illicit drug use;

• Participation in a clinical trial in the year prior to this study;

• Pregnancy or risk of pregnancy and lactating patients;

• Known hypersensitivity to the formula components used during the clinical trial;

• Type 1 diabetes mellitus;

• Fasting blood glucose > 300 mg/dL;

• Risk factors for volume depletion;

• Impaired renal function and end-stage renal disease;

• Participants with current treatment and continued for more than 15 days with systemic steroids at the time of informed consent;

• Impaired hepatic function;

• Medical history of pancreatic diseases that may suggest insulin deficiency;

• Bariatric surgery in the last two years and/ or other gastrointestinal surgeries that can cause chronic malabsorption syndrome;

• Condition that, in the investigator's judgment, may favor clinically significant changes in CPK levels;

• Medical history of acute coronary syndrome, stroke, unstable congestive heart failure, or respiratory failure within 6 months prior to informed consent;

• Current medical history of cancer and/ or cancer treatment in the last 5 years;

• Medical history of metabolic acidosis and/or using drugs that may cause lactic acidosis;

• Medical history of blood dyscrasia or any other hemolytic disorders;

• Participants using sulfonylureas and/or insulin therapy;

• Treatment with anti-obesity drugs for less than 2 months or with dose change in the last 2 months.